Erythropoietin Therapy for Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650415
• Other study ID #: CPEPO
• Status: Completed
• Phase: Phase 2
• First received: July 24, 2012
• Last updated: October 10, 2017
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2017
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized placebo-controlled trial aims to investigate the efficacy and safety of erythropoetin for children with cerebral palsy.

Description:

Cerebral palsy is a disorder of movement and posture resulted from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed as follows;

1. Neuroprotection effect

2. Angiogenesis

3. Anti-inflammation.

On the basis of many experimental studies, erythropoietin is suggested as a therapeutic method for cerebral palsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 4 Years

Eligibility

Inclusion Criteria:

• Cerebral Palsy

• Abnormal Muscle Tone

• Abnormal Brain MRI

• Willing to Comply with All Study Procedure

Exclusion Criteria:

• Known Genetic Disorder

• Other Etiologies Contributing Developmental Delay

• Coagulopathy

• Initial high Erythropoietin level in Serum

• Previous Erythropoietin Treatment before 3 months

• Presence of Drug Hypersensitivity Related to the Study Remedy

• Intractable Seizure Disorder

• Poor Cooperation of Guardian including Inactive Attitude for Rehabilitation

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Drug:
• Erythropoietin
twice a week for 1 month
• Placebo erythropoietin
twice a week for 1 month

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Bundang CHA Hospital	LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Quality of Movement	GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones: alignment, coordination, dissociated movement, stability, and weight shift. The interrater reliability of GMPM subscores and total scores was 0.758-0.886 (subject n=75, tester n=10).	Baseline - 2 months
Secondary	Changes in Gross Motor Function	GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of 6 sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping. The measured interrater reliability of GMFM subscores and total scores was 0.974 - 0.997 (subject n=101, tester n=10) and intrarater reliability of GMFM subscores and total scores between one most experienced rater and another newly t rained rater was 0.994 - 1.000 (subject n=101, tester n=2).	Baseline - 2 months
Secondary	Changes in Neurodevelopmental Outcomes	K-BSID-II (Korean version of Bayley Scale of Infant Development-II) Motor and Mental Scales. The measured intrarater and interrater reliability of K-BSID-II motor and mental scales was 0.92 - 0.99 (subject n=55, tester n=10).	Baseline - 2 months
Secondary	Changes in Motor Development	AIMS (Alberta Infant Motor Scale)to measure the motor development	Baseline - 2 months
Secondary	Changes in Spasticity	MAS (modified Ashworth Scale)measured at biceps, hip adductor, hamstring, heel cord	Baseline - 2 months